The aim of this study is to investigate the effects of Curcumin on bone loss and bone turnover markers in patients with Spinal Cord Injury (SCI) . The study was double-blind clinical trial on patients referred to the Neurosurgery clinic. Inclusion criteria: age equal to 18 years, trauma, recent SCI (less than 6 months), paraplegia or quadriplegia. Exclusion criteria: any secondary cause of osteoporosis such as metabolic or endocrine disease. The patients were divided randomly into two case and control. Patients in case group 100 mg / kg / day of Curcumin intravenously received for 6 month. All clinical examination and biochemical markers of bone turnover assaying and also densitometry measurements of patients at baseline and 6 months after the intervention were performed for all patients. Statistical analysis was performed end-to interpret result.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010225805N1
Registration date:2016-04-21, 1395/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Masoud Hatefi
Name of organization / entity
Ilam University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7150
Email address
hatefi-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin on bone density loss and biochemical marker of bone turn over in patient with Spinal Cord Injury
Public title
Effect of Curcumin on Osteoprosis in patient with Spinal Cord Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age equal to 18 years; trauma; recent SCI (less than 6 months); paraplegia or quadriplegia move engagement protocol spinal cord injury America Association (ASIA).
Exclusion criteria: any secondary cause of osteoporosis such as metabolic or endocrine disease; osteogenesis imperfecta; tumors; chronic cardiovascular diseases; liver; anti-osteoporosis medications during the selection of patients; Alcoholism; pregnancy; chronic use of steroids; smoking; older than 70
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences, Ilam, Iran
Street address
Ilam
City
Ilam
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
ir.medilam.rec.1394.186
Health conditions studied
1
Description of health condition studied
spinal cord injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Bone Density of Total Hip
Timepoint
Before intervention and 6 month after intervetion
Method of measurement
Dansitometry Lab
2
Description
Bone Density of lumbar vertebral (L1-L4)
Timepoint
Before intervention and 6 month after intervetion
Method of measurement
Laboratory assay
3
Description
Bone Density of Femoral Neck
Timepoint
Before intervention and 6 month after intervetion
Method of measurement
Laboratory assay
4
Description
Bone Specific alkaline phsphatase
Timepoint
Before intervention , 3 month after intervention and 6 month after intervetion
Method of measurement
ElISA
5
Description
Propeptide amino-terminal of type I procollagen
Timepoint
Before intervention and 6 month after intervetion
Method of measurement
ElISA
6
Description
Osteoclacin
Timepoint
Before intervention and 6 month after intervetion
Method of measurement
ElISA
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Calcium Plus(Caspian Tamin co, Iran) 1000 mg daily for 6 months
Category
Treatment - Drugs
2
Description
Intervention group: Curcumin (Mina Laboratory co,Iran) 110 mg/kg daily for 6 months+ Calcium Plus 1000 mg daily for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Clinic of Imam Khomeini in Ilam city
Full name of responsible person
Masoud Hatefi
Street address
Neurosurgery Clinic, Imam Khomeini Hospital, Street 22 Bahman, Ilam city, Ilam, Iran.
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ilam University of Medical Sciences
Full name of responsible person
Dr Kourosh Sayhemiri
Street address
Ilam University of Medical Sciences, boulevard Research, Ban Ganjab, Ilam city, Ilam, Iran
City
Ilam
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Hafezi Ahmadi
Position
Pathologist
Other areas of specialty/work
Street address
School of Medicine, Ilam University of Medical Sciences, boulevard Research, Ban Ganjab, Ilam city, Ilam, Iran
City
Ilam
Postal code
Phone
+98 84 3224 3320
Fax
Email
reza.ahmadi65@yahoo.com; hafezi-m@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Mohammad Reaza Hafeizi Ahmadi
Position
Pathologist
Other areas of specialty/work
Street address
Ilam University of Medical Sciences, boulevard Research, Ban Ganjab, Ilam city, Ilam, Iran
City
Ilam
Postal code
00988432243320
Phone
+98 84 3224 3320
Fax
Email
reza.ahmadi56@yahoo.com, hafezi-m@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Sara Mohammadnejad
Position
Msc Geriatric Nursing
Other areas of specialty/work
Street address
School of Nursing, Ilam University of Medical Sciences, boulevard Research, Ban Ganjab, Ilam city, Ilam, Iran
City
Ilam
Postal code
Phone
+98 84 3224 3320
Fax
Email
Saranursing68@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)